The pharmaceutical industry's efforts to self-regulate its direct-to-consumer (DTC) advertising are "an industry-sponsored ruse" intended to deflect criticism and collectively block new US federal regulation, a new study claims.

Reporting in the Journal of Health Politics, Policy and Law, the researchers studied the US marketing campaigns for three erectile dysfunction (ED) drugs - Pfizer's Viagra (sildenafil citrate), Eli Lilly's Cialis (tadalafil) and Bayer HealthCare's Levitra (vardenafil), marketed in the US by Bayer Healthcare, GlaxoSmithKline and Merck & Co - from 2006 to 2010.

All these companies have certified compliance with the Guiding Principles developed by the Pharmaceutical Research and Manufacturers of America (PhRMA). Under these guidelines, a company must commit to internal processes to ensure compliance with the Principles, complete an annual certification of compliance and submit a document to PhRMA signed by the CEO and chief compliance offer attesting to compliance, note the study authors, Denis Arnold of the Belk College of Business at the University of North Carolina at Charlotte and Jim Oakley of Montana State University.

However, the authors say they found "a clear pattern of non-compliance" to the Guiding Principles for the three drugs: - Eli Lilly's Cialis campaign consistently violated six principles, partially complied with two principles and fully complied with one; - Pfizer's Viagra campaign consistently violated five principles, partially complied with one principle and fully complied with two; and - Bayer Healthcare/GSK/Merck & Co's campaign for Levitra consistently violated five principles, partially complied with three and fully complied with one.

Advertising spend for ED drugs grew 56% between 2006 to 2009, from $200 million to £313 million, and television advertising accounts for about 80% of total DTC ad spending, the study reports. Since 2006, US consumers have been exposed to around ED television advertising "impressions," of which over 100 billion were seen by consumers aged under 18, in violation of the Guiding Principles.

Each of the companies has stated that they are in compliance with the principles' requirement that 90% of the audience for adult-themed broadcast ads be aged 18 or older, but Arnold and Oakley say their analysis of AC Nielsen data documents that this claim has not been true for any quarter during the four-year period of the study.

The patient information and print ads were consistently found to exceed recommendations for consumer legibility, and each of the drugs was presented in the ads as the most appropriate first-stage treatment for disease - none effectively informed consumers of alternative options for treatment, all of which is in violation of the Guiding Principles.

The authors also claim that the mechanism set up by PhRMA for consumers to make complaints "does not function - the fax machine is typically not connected and complaints go unanswered,” they say. They also point out that PhRMA does not make violations of its Guiding Principles public, nor does it sanction member violations.

"The Guiding Principles were introduced, at least in part, to preclude the need for additional federal regulation of broadcast drug advertising. In this regard they have been largely successful," say the authors. But, they add: “cumulatively, our data shows that ED marketing campaigns fail to responsibly educate consumers about health conditions and appropriate treatments. Instead of facilitating a balancing of interests between company profits and public health, the illusion of industry self-regulation is primarily serving the interest of pharmaceutical companies at the expense of the public's interest in genuine health education and welfare." 

Among their recommendations to rectify what they see as the ineffectiveness of the industry-developed self-regulation, Arnold and Oakley call for a "more robust" regulatory climate. They also suggest establishing a fee for each DTC advertising broadcast, to enable the US National Library of Medicine to produce and widely distribute plain-English information about the benefits, harms and costs of the drugs advertised, as well as information about the condition and non-pharmacological treatment options.